Director Global Regulatory Strategy - Permanent Position

LGBT Jobs; Hatfield; Hybrid; GBP 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid working

Car allowance

EV charging points

Discretionary Bonus

Free onsite parking

Onsite restaurant & coffee shop

Learning & development

Well-being programs

Prayer room

Job summary

Eisai seeks a Director, Global Regulatory Strategy to lead the submission of Neurology clinical trial applications and product registration dossiers, guiding regulatory strategy across the product lifecycle.

Based at Eisai's EU Headquarters EKC with hybrid working, the role requires extensive interaction with global agencies to accelerate approvals and ensure compliance across indications and devices.

Qualifications

• Extensive experience in direct Regulatory Affairs within biotech/biopharma.
• Proven track record interfacing with global regulatory agencies (EMA).
• Experience with Clinical Trial Applications, submissions and maintenance.
• Pediatric Investigation Plan experience is advantageous but not required.
• Strong understanding of regulations governing pharmaceutical development and registration.

Responsibilities

• Direct submission of Neurology clinical trial applications and regulatory dossiers.
• Provide strategic direction to project teams on interactions with agencies to expedite approvals.
• Serve as regulatory liaison to project teams throughout the product lifecycle.
• Ensure trial designs meet regulatory requirements and timely approvals for drugs and devices.
• Advise on development strategies and collaborate with partners on regulatory matters.

Skills

Regulatory Affairs

Global regulatory agencies

Clinical Trial Applications

Pediatric Investigation Plan

Regulatory guidelines

Job description

Director Global Regulatory Strategy - Permanent Position

Director Global Regulatory Strategy - Permanent Position

Location: Mosquito Way, Hatfield AL10 9SN, UK

Highlighted points for this job

Director, Global Regulatory Strategy role

Focus on Neurology clinical trial applications and product registration

Hybrid working and comprehensive benefits package

Extensive industry experience required

Based at EMEA Knowledge Centre in EU Headquarters

The Company

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.

By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.

Your new role

As a Director, Global Regulatory Strategy, you will direct the development of submission of Neurology clinical trial applications, product registration dossiers, supplements, amendments. Provide strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. Interact and negotiate with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serve as a regulatory liaison on the project team throughout the product lifecycle. Ensure that clinical trial designs meet regulatory requirements. Ensure rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serve as regulatory representative to project team, developing regulatory strategy for Eisai assets and providing advice on all aspects of product development from a regulatory perspective. Support collaboration development with partners.

What are we looking for?

• Extensive industry experience with demonstrated experience in direct Regulatory Affairs in the biotech/biopharmaceutical industry.
• Demonstrated track record of interfacing effectively with global regulatory agencies, such as the EMA
• Experience Clinical Trial Applications, including submission and maintenance
• Paediatric Investigation Plan experience preferred but not required
• Strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration.

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes,

• Hybrid working (Depending on role)
• Car/Car Allowance (Depending on role)
• Electric charging points for Electric/Hybrid vehicles
• Discretionary Bonus
• Free onsite parking
• Subsidised onsite restaurant and coffee shop
• Learning and development opportunities
• Well-being & mental health awareness programmes
• Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society. Our commitment is:

to embrace and celebrate our differences, respecting and valuing each other.

to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.

to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity